Palonosetron and palonosetron plus dexamethasone to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A prospective, randomized, double-blind comparative study (original) (raw)
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Journal of Evolution of Medical and Dental Sciences
BACKGROUND Postoperative nausea and vomiting is the most common and unpleasant event following laparoscopic cholecystectomy often involving multifactorial pathways and receptors. Combination prophylaxis acting through different mechanisms has been shown to be superior to the use of a single agent in prevention of PONV. We designed this study to find out and compare the efficacy of preoperative palonosetron and palonosetron with dexamethasone for the prevention of Postoperative Nausea and Vomiting (PONV) following elective laparoscopic cholecystectomy under general anaesthesia. MATERIALS AND METHODS A total of 100 patients of American Society of Anaesthesiologists (ASA) physical status I and II patients, aged 18 to 65 years, weighing 40-75 kg scheduled for elective laparoscopic cholecystectomy were enrolled and divided into palonosetron (P) group (n = 50) and Palonosetron Dexamethasone (PD) Group (n = 50). Group P patients received Inj. palonosetron 0.075 mg IV and Group PD patients received a combination of Inj. palonosetron 0.075 mg with Inj. dexamethasone 8 mg IV in a randomised and doubleblinded approach. Nausea, retching, vomiting, complete response, rescue antiemetic and any side effects were evaluated postoperatively. Statistical Package for Social Sciences (SPSS Inc. Chicago IL, USA) windows based version 21.0 was used for analysis of data. Comparisons between groups were performed by using the independent t-test and Chi Square test. P < 0.05 was considered to be statistically significant. RESULTS The incidence of complete response was higher in PD Group than P Group during 0-2 hrs. (86% vs 70%) (P = 0.045 and 0-48 hrs. (86% vs 70%) (P = 0.045) postoperative periods. The use of rescue antiemetic was lower in PD Group (14% vs 30%) (P = 0.045) during 0-2 hrs. and 0-48 hrs. (14% vs 30%) (P = 0.045). CONCLUSION Combination prophylaxis of intravenous palonosetron 0.075 mg and dexamethasone 8 mg is more effective than palonosetron in the prevention of PONV in patients undergoing laparoscopic cholecystectomy under general anaesthesia without any major adverse effects.
BACKGROUND Postoperative nausea and vomiting is the most common distressing symptom after surgery. Women undergoing laparoscopic surgeries are particularly at risk. This study compares the antiemetic efficacy of ondansetron and palonosetron in females undergoing laparoscopic cholecystectomy. MATERIALS AND METHODS A total of 80 subjects between 18-65 years were randomly allocated into two groups of 40 each, Group O and Group P. Patients in Group O received injection ondansetron 4 mg intravenously and those in Group P received injection palonosetron 0.075 mg intravenously just prior to induction of anaesthesia. The incidence of postoperative nausea and vomiting (PONV), rescue antiemetics and any side effects were recorded in the first 24 hours. At the end of 24 hours, patient satisfaction was assessed with a 5-point scale. RESULTS The incidence of PONV requirement of rescue antiemetics and patient satisfaction score were comparable in both groups. There was no significant difference in side effects seen between the two groups. CONCLUSION The effects of palonosetron in preventing PONV was comparable to that of ondansetron after laparoscopic surgery.
Background: Postoperative nausea and vomiting (PONV) are commonly observed undesirable and potential complications in patients after laparoscopic cholecystectomy (LC) and chemotherapy. PONV are commonly observed adverse effects of general anaesthesia (GA) and its incidence ranges between 60% to 72 % following laparoscopic cholecystectomy. Methods: In a prospective, double blinded, randomized controlled study, and after Ethical Committee years who underwent elective LC under GA were studied during a two year period in a tertiary care teaching hospital, in Imphal were assigned in one of two groups viz: Group PD (n=50) received 0.075 mg palonosetron with 8 mg dexamethasone and group GD (n=50) received granisetron 40 µg/kg body weight plus 8 mg dexamethasone. Nausea, retching and vomiting (PONV), complete response, rescue antiemetic and any side effects were observed upto 48 hours postoperatively. Results: The incidence of ponv was 12% and 14% in group PD and group GD respectively in 0-2 hrs interval and 14% and 22% in 2-48 hrs interval, respectively. However group PD had lesser incidence of PONV than group GD ( p>0.05). Conclusion: It may be concluded that prophylactic intravenous palonosetron with dexamethasone is as effective as granisetron and dexamethasone, in prevention of early PONV. Although statistically insignificant, palonosetron and dexamethasone was better than granisetron and dexamethasone in prevention of late PONV in LC under general anaesthesia.
Background: Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of Palonosetron and Granisetron for the prevention of PONV in patients undergoing laparoscopic cholecystectomy. Methods: In this prospective, randomized observational study, 70 patients who were undergoing laparoscopic cholecystectomy under general anaesthesia were enrolled. Patients were divided into two groups: the palonosetron (1.5 mg/kg,i.v.; n = 35), and granisetron group (0.05mg/kg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated. Results: The overall incidence of PONV was 26.5 % for this series. The number of complete responders at 48 hr after the surgery was 20 (57 %) for granisetron, and 23 (65%) for palanosetron representing no statistical difference (P = 0.086). Conclusions: Palanosetron is more effective in prevention of PONV in patients undergoing laproscopic cholecystectomy surgeries as compared to granisetron especially in 24-48 hr period postoperatively. Introduction Laparoscopic surgeries are the second most common cause of postoperative nausea and vomiting (PONV), a frequent and disturbing complication of surgery and anaesthesia [1]. The incidence of PONV after laproscopic surgery is around 25-30% but laparoscopic cholecystectomy is reported to be nearly 80 % [2] and can result in prolonged hospital stay and recovery times. Numerous antiemetics have been studied to prevent and treat PONV after laparoscopic
IP Innovative Publication Pvt. Ltd., 2017
Introduction: In this randomized, double-blind study we evaluated the relative efficacy of palonosetron (a new, selective 5hydroxytryptamine [5-HT3] receptor antagonist) and ondansetron in preventing postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy surgery. Materials and Method: Patients were given either palonosetron 0.075 mg (n = 50) or ondansetron 8 mg (n = 50) intravenously, just before anaesthesia. The occurrence of nausea and vomiting and the severity of nausea according to a visual analogue scale were monitored immediately after the end of surgery and during the following 24 hour post surgical period in time intervals of 0-4,4-8,8-12 and 12-24 hour period. Result: The incidence of PONV and nausea (not vomiting) was significantly lower in the palonosetron group than in the ondansetron group during the 24 hour post surgical period (P < 0.05). More patients in the palonosetron group had a complete response (no PONV and no need of rescue antiemetic) compared with the ondansetron group. The need for rescue antiemetics was significantly lower in the palonosetron group than in the ondansetron group during the 24 hour post surgical period (P <0.05). The severity of nausea (VAS) and incidence of adverse effects were not significantly different between the two groups. The incidence of PONV was significantly lower in the palonosetron group compared with the ondansetron group (32% vs 56%, respectively). Conclusion: Palonosetron 0.075 mg was more effective than ondansetron 8 mg in preventing postoperative nausea and vomiting (PONV).
American Journal of Therapeutics, 2012
Background: Postoperative nausea and vomiting (PONV) is a common complication after anesthesia and surgery; 5-hydroxytryptamine type 3 (5-HT 3) receptor antagonists have been considered as a first-line therapy. Ramosetron and palonosetron are more recently developed drugs and have greater receptor affinity and a longer elimination halflife compared with older 5-HT 3 receptor antagonists. The purpose of this study was to determine which drug is more effective for preventing PONV between ramosetron and palonosetron. Methods: We enrolled 100 patients undergoing gynecological laparoscopic surgery into this study. The subjects were divided into ramosetron group and palonosetron group. The medications were provided immediately before the induction of anesthesia. The occurrence of nausea and vomiting, severity of nausea according to a visual analogue scale, and rescue anti-emetic drug use were monitored immediately after the end of surgery and at 0-6 h, 6-24 h, and 24-48 h post-surgery. Results: The incidence of vomiting was significantly lower in the palonosetron group than in the ramosetron group during 0-6 h (6% vs 26%, P = 0.012) and 0-48 h (14% vs 34%, P = 0.034). The incidence of nausea and overall PONV, and the use of rescue antiemetic were not significantly different during all time intervals. The severity of nausea was not different between the two groups. Conclusions: In conclusion, the incidence of PONV between the ramosetron and the palonosetron group have not shown the difference during 0-48 h, although palonosetron results in a lower incidence of vomiting during 0-6 h post-surgery.
Asian Journal of Pharmaceutical and Clinical Research, 2018
Objectives: Post-operative nausea and vomiting (PONV) is a frequently experienced complication following laparoscopic cholecystectomy. This study was planned to compare the antiemetic efficacy of palonosetron with ondansetron in patients undergoing laparoscopic cholecystectomy.Methods: A total of 100 patients undergoing laparoscopic cholecystectomy were randomized into two groups. Group O (n=50) received ondansetron (8 mg) and Group P (n=50) received palonosetron (0.075 mg) 3 min before induction of anesthesia. Post-operatively, patients were assessed for the occurrence of nausea, retching, or vomiting at 0–2, 2–6, 6–24, 0–24, and 24–48 h time intervals. The overall incidence of PONV in time frame (0–48 h) was determined. The need of rescue antiemetic, side effect profile, and patient satisfaction scores were also assessed.Results: The incidence and severity of nausea at all the time intervals were comparable in the two groups. The incidence of vomiting was significantly less in Gro...
Anesthesia: Essays and Researches, 2011
Background: Postoperative nausea and vomiting (PONV) is a serious concern in patients undergoing laparoscopic cholecystectomy (LC), with an incidence of 46 to 72%. The purpose of this study was to compare the antiemetic efficacy of intravenous (iv) ondansetron 8 mg, ramosetron 0.3 mg, and palonosetron 0.075 mg for prophylaxis of PONV in high-risk patients undergoing LC. Materials and Methods: In this prospective, randomized, double-blinded study, 87 female patients, 18 to 70 years of age (ASA I and II) and undergoing elective LC under general anesthesia were randomly allocated into three equal groups, the ondansetron group (8 mg iv; n=29), the ramosetron group (0.3 mg iv; n=29), and the palonosetron group (0.075 mg iv; n=29), and the treatments were given just after completion of surgery before extubation. The incidence of complete response (patients who had no PONV and needed no other rescue antiemetic medication), nausea, vomiting, retching, and need for rescue antiemetics over 24 hours after surgery were evaluated. Results: The number of complete responders were 19 (65.5%) for ramosetron, 11 (37.9%) for palonosetron, and 10 (34.5%) for ondansetron, representing a significant difference overall (P=0.034) as well as between ramosetron and ondansetron (P=0.035). Comparison between ramosetron and palonosetron also showed a clear trend favoring the former (P=0.065). Conclusion: Ramosetron 0.3 mg iv was more effective than palonosetron 0.075 mg and ondansetron 8 mg in the early postoperative period, but there was no significant difference in the overall incidence of nausea suffered.
IP Innovative Publication Pvt. Ltd., 2018
Introduction and Aims: Postoperative nausea and vomiting (PONV) are very common and distressing adverse events after general anaesthesia. Palonosetron and ramosetron are newer, second generation, selective 5-HT3 receptor antagonists. The present study was carried out to compare the efficacy and safety of palonosetron and ramosetron for prevention of postoperative nausea and vomiting (PONV) over the period of 72 hours in patients undergoing for laparoscopic surgery under general anaesthesia. Materials and Methods: 80 patients of ASA class I and II undergoing for various laparoscopic surgeries were randomly allocated into 2 groups of 40 each, to receive Inj. palonosetron 75 ?g (group P) or Inj. Ramosetron 0.3 mg (group R). Patients were monitored for emesis, severity of nausea, requirement of rescue antiemetic and complete response up to 72 hours (0-6, 6-24, 24-72) post operatively. Results: During 0-6 hours, severity of PONV was comparable in both drug groups but during 24-72 hours, PONV score 2 was observed in 5% and 17.5% of patients of group P and group R respectively (p=0.027). While score 3 was observed in 15% of patients of group R and none of the patients of group P (p=0.01). On comparison of complete response between Group P and Group R, at 0-6 hours response was almost equal but during 6-24 hours and 24-72 hours number of patient having complete response were more in Group P (97.5% and 82.5%) as compared to Group R (65% and 57% respectively). Conclusion: Palonosetron given as a prophylaxis for post-operative nausea and vomiting (PONV) in patients undergoing for laparoscopic surgeries seems to have better antiemetic effect over ramosetron. Keywords: PONV, Palonosetron, Ramosetron, Laparoscopic surgery.
IP innovative publication pvt. ltd, 2019
Introduction: The incidence of postoperative nausea and vomiting (PONV) following laparoscopic surgeries is very high without antiemetic prophylaxis. 5HT3 receptor antagonists are the most commonly used drug for prevention of PONV. Aims: To compare the effectiveness of intravenous (IV) palonosetron versus ramosetron in prevention of PONV during the 24 hour period in patients undergoing laparoscopic surgeries. Materials and Methods: Sixty patients enrolled for the study were randomly allotted into two groups of thirty each. Group I received 0.075 mg of IV Palonosetron and Group II received 0.3 mg of IV Ramosetron two minutes before induction of anaesthesia. Both the Groups were similar with respect to age, sex, duration and types of surgery and anaesthetic management. Patients were assessed for the incidence of nausea, retching, vomiting, need for rescue antiemetic and adverse effects at 0-2 hour and 2-24 hours interval following surgery. Students 't' test and chi-square test were used for comparing the parameters. A p-value <0.05 was considered significant. Results: There was no significant difference between the groups with respect to incidence of nausea, retching and vomiting. The incidence of nausea in group I at 0-2 hours was 3.3% and 6.7% in Group II without a statistically significant difference (p=0.5) and at 2-24 hour interval Group I had 3.3% while Group II had 10% incidence of vomiting with p=0.3 and statistically non-significant. There was no significant difference with respect to incidence of retching, vomiting, need for rescue antiemetic and adverse effects between the two groups. Conclusion: Both palonosetron and ramosetron are equally effective in prevention of PONV in laparoscopic surgeries.